Policy
Under the $1.4 billion Project NextGen initiative, Regeneron was awarded a $326 million grant for its preventive monoclonal antibody, while Johnson & Johnson got $10 million to bankroll startups.
FEATURED STORIES
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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Pfizer and BioNTech initiated a Phase II trial of an enhanced COVID-19 vaccine while fending off lawsuits against CureVac and Alnylam over their technology.
Teva expects to finalize and complete the documentation needed in the coming weeks, followed by a nationwide sign-on process for states, subdivisions and Native American tribes.
Martin Shkreli, commonly known as the “Pharma Bro,” announced Monday he has cofounded Druglike, a Web3 drug discovery software platform, despite a lifetime ban from the pharma industry.
WHO declared the monkeypox outbreak a “public health emergency of international concern [PHEIC].” As COVID-19 wanes, Tonix, SIGA, Emergent Bio and others are now targeting monkeypox.
The U.S. Attorney’s Office was busy indicting nine people for charges related to insider trading. Some charges were unrelated, but three were specific to the biopharma industry.
The complaint alleges the agencies made an error under the Administrative Procedure Act, violating the Food Drug and Cosmetics Act by failing to approve Lumryz.
The announcement signals that the WHO now views the outbreak as significant enough that a coordinated global response is necessary to control it.
FDA Weekly Review looks at the FDA’s actions related to drug approvals, IND approvals, designations and more. Here’s a look at what happened this week.
Pfizer and Flynn Pharma are under the scrutiny of British watchdogs once again, after officials said the companies have been overcharging for an anti-epilepsy medication in the U.K. for over four years.
The whistleblower claim was brought by former employee Michael Bawduniak, who accused the company of paying off doctors to favor its multiple sclerosis drugs over those of its competitors.